Ultrasound guidance system

ABSTRACT

A compact ultrasound needle guidance system and method of use is described. The needle guidance system has components to adjustably target a needle&#39;s destination in the plane of a two-dimensional ultrasound image before insertion of a needle into a patient. Needle movement is tracked using a position detector that provides a visual display of the needle path on the ultrasonic image.

FIELD OF INVENTION

The present invention relates generally to ultrasound systems and, moreparticularly, to ultrasound guidance systems. This application claimspriority under 35 U.S.C. §119(e) to U.S. Provisional Application No.60/714,192 filed Sep. 2, 2005 and U.S. Provisional Application No.60/808,552 filed May 26, 2006.

BACKGROUND OF INVENTION

As an inexpensive and noninvasive technique, ultrasound is useful as amedical imaging modality able to provide real time feedback in atwo-dimensional fashion at a patient's bedside. Ultrasound facilitatesdozens of procedures performed in hospitals and clinics every day, withthese procedures ranging from breast biopsies to central line catheterinsertion to amniocentesis.

In a typical ultrasound guided procedure, a doctor will place a small,handheld probe known as a transducer on a patient's skin. The transducerconverts electrical energy to acoustic energy. Acoustical energy istransmitted from the transducer and into the patient's body in the formof sound waves. The transmitted sound waves are either reflected backtowards the transducer or absorbed by the medium, depending on theacoustical impedance. For example, a bone or fat, having relatively highacoustical impedance, reflects the sound waves with little or noattenuation of the sound wave, while a vein or artery, having arelatively low impedance, will absorb acoustical energy. The reflectedsound waves are converted into electrical signals which are used to forma real time two-dimensional image of a portion of the patient's body.

This image may be used to assist a health professional with locating aregion of the patient's body for purposes of locating the point where aninvasive medical device, e.g., a needle, is inserted. After locating thecorrect insertion point, the health professional may then begin themedical procedure, such as insertion of a catheter, administration of alocal anesthetic, or removal of tissue as in a biopsy.

It is sometimes difficult to accurately track the path and position ofthe medical device after it has entered the patient's body on themonitor. The medical device, e.g., a needle, is not typically visualizedby the ultrasound image, which is essentially a two-dimensional image.Unless the needle is positioned exactly in-plane with the image, theneedle is not visible or only partially visible, which means that theneedle location or, more importantly the location of the needle tip, isnot known exactly. As such, a health professional will often makenumerous attempts to insert the device before he or she can see thetarget tissue mass or blood vessel buckle under the force of the needlepressing against it. And in the case where the target is, for example, anerve, the health professional often times can only estimate thelocation of the needle end if it is not visible on the ultrasound image.Such an error-prone, user-dependent procedure is painful for thepatient, time consuming for the health professional, and incurs possibleadditional liability for the hospital with each use. Procedures forusing an ultrasound imaging device for peripheral nerve blocks aredescribed in Anna Dabu BScH, and Vincent W S Chan, MD, FRCPC A PracticalGuide to Ultrasound Imaging For Peripheral Nerve Blocks (copyright 2004by Vincent W S Chan, MD, FRCPC), the contents of which are incorporatedherein by reference in its entirety.

There are multi-planar ultrasound imaging devices capable of producing athree-dimensional image of the body, which may be capable of moreaccurately locating the position of an invasive medical device, butthese types of devices are typically expensive to operate, and require arelatively high degree of skill and training to operate. It would bedesirable if a low-cost device, capable of being used effectively by ahealth professional with moderate or little training in ultrasoundimaging techniques, were available which could accurately locate theposition of the medical device beneath the skin. This would eliminatemuch of the “guesswork” that is involved in locating a medical device atthe point of interest.

Existing ultrasound devices can be characterized by the approach of theneedle-guided insertion with respect to the plane of the ultrasoundbeam. In the “transverse” type, the medical device, e.g., needle, isorientated out of plane and is sometimes disfavored becausevisualization of the needle is not reliable as it passes through thepatient's body. The “longitudinal” type has the added advantage ofseeing the entire length of the needle because it is inserted in planewith the ultrasound beam; however, it can be difficult to keep theneedle in the plane of the transducer image due to operator skill andinherent needle-bending when passing through tissue.

While the longitudinal type device is preferred because there is greaterchance of tracking the needle, it is also more difficult to position theneedle at the target when the needle is planar with the image. Atransverse needle pathway, on the other hand, is more intuitive, isshown to be easier for novice ultrasound users, and is the preferredapproach for various procedures according to experts. The followingthree studies have been conducted which compare the performance oflongitudinal verses transverse type of ultrasound guidance devices, allof which are incorporated herein by reference: P. Marhofer, M. Greherand S. Kapral, Ultrasound guidance in regional anesthesia, BritishJournal of Anasthesia 94 (1): 7-17 (2005); M. Blaivas, L. Brannam, andE. Fernandez, Short-axis verses Long-axis Approaches for TeachingUltrasound-guided Vascular Access on a New Inanimate Model, ACAD EmergMed, Vol. 10, No. 12 (December 2003); and B. D. Sites, J. D. Gallagher,J. Cravero, J. Lundberg, and G. Blike The Learning Curve Associated Witha Simulated Ultrasound-Guided Interventional Task by InexperiencedAnesthesia Residents, Regional Anesthesia and Pain Medicine, Vol. 29,No. 6 (November-December 2004), pp. 544-548.

One known ultrasound device for assisting a health professional withneedle placement in a body is the Ilook™ personal imaging tool, sold bySonoSite, Inc., which includes a series of removable needle guides. Thedevice is used to place a needle at a target location beneath theskinline by real-time visual identification of the target via anultrasonic image. A bracket, located on the front of the transducer, isused to mount a needle guide. The needle guide is orientated such that aneedle received therein will extend approximately perpendicular to thesonic scanning plane. Thus, the SonoSite, Inc. device is atransverse-type device. When it is time to perform the procedure, thedevice is wrapped in a sterile sleeve (an acoustic coupling gel is putinto the sleeve and the sleeve is placed over the transducer) and thesleeve is sealed using a rubber band. The sleeve covers the transducerand bracket. The procedure for use includes inserting the acousticcoupling gel into the sleeve, covering the device with the sleeve,ensuring there are no cuts or tears in the sleeve, then securing thesleeve with a rubber band. After this sterilization of the transducer, asterile needle guide is snap-fit on the bracket. There is more thanone-type of needle guide to choose from. The choice depends upon thedistance between the skinline and the top of the vessel. Three choicesare available for this particular device: a 1 cm, 2 cm and 3 cm needleguide that reflect an approximate depth of the target vessel beneath theskinline. These different lengths correspond respectively to increasingangular inclinations of the needle relative to the skinline.

The needle guide has a door that can be locked in a closed position by aslidable switch, thereby retaining the needle shaft between the door anda semi-circular recessed area. The needle is placed in this recessedarea and the door is closed to hold the needle therein. The transducerwith needle is then placed on the skinline and the top of the vessel islocated via the sonic image. The needle is then inserted into the body.

After the needle has reached the target, the transducer needs to beremoved from the needle, which requires unlatching the door of theneedle guide. This procedure can cause complications as it is oftennecessary to maintain precise positioning of the needle within the body.When the door is being unlatched, there can be unacceptable motion ofthe transducer (and therefore of the needle) as a result of overcomingmechanical resistance in the latch.

Another known ultrasound imaging device is the Site-Rite® UltrasoundSystem by Bard Access Systems. This device also provides a needle guideto hold the needle at a fixed angle with a transverse approach and isoperated in a similar manner as the SonoSite, Inc. device describedabove. A health professional first places the transducer such that atarget of interest (e.g. a vessel's lumen) is visible on the screen. Thelocation of the target is then estimated and a needle guide is selectedsuch that the needle will pass closest to the target's location. Becausethe entire probe is enclosed in a sterile sleeve, the needle guide istypically disposable and kept sterile until use. When needed, the needleguide is clamped to the probe through the sterile sleeve. Each needleguide is set to a static angle which is not adjustable. If the insertionangle needs to be corrected, the needle guide must be removed andsubstituted with a different needle guide. Additionally, after insertingthe needle into the target, the probe must be rocked to pry the needlefrom the needle guide, potentially disrupting the needle-targetinteraction. This is because the needle guide is a one piece needleguide with lips that are flexed to release the probe from the needle.

U.S. Pat. No. 6,695,786 discloses a longitudinal-type ultrasound devicefor biopsy procedures. The device has a biopsy needle guide coupled toan ultrasound probe. The needle guide has a needle holder connected tothe probe by a link assembly that allows a user to rotate the biopsyneedle, but without allowing the user to twist or bend the needleoutside the imaged plane. Other examples of longitudinal-type devicesare described in U.S. Pat. No. 4,058,114 and U.S. Pat. No. 4,346,717.

Known ultrasound monitors are typically fixed to a stand. In thesesystems, a health professional often must turn his or her head to focuson the screen. Also, these devices have cords connecting the ultrasoundprobe to the monitor which are typically much longer than needed formost procedures because it must be sufficiently lengthy for extremecases. As a result, the cord can often obstruct the probe's user.Additionally, the probe cannot be maintained in a sterile condition whenit is placed on a holder provided with the system.

There is a need for a user-friendly ultrasound system that requires onlya relatively low-degree of training and/or skill in ultrasound imagingtechniques. It would also be desirable to have a device that reduces theerror rate and/or discomfort to the patient when locating targets duringinvasive procedures, and that offers health professionals the ability todirect needles to a target of any depth when the needle is controlled ina plane perpendicular to the scanning plane. It would also be desirableto have a device that is capable of being used in any invasive procedurewithout additional health costs charged by a health provider; a devicethat can be pre-aimed at a target and before insertion into a livingbody; a device that provides easy visibility of the ultrasound image andmedical device in real time; and a device that is adapted for releasablyfastening an invasive medical device to a probe or imaging device so asto reduce incidences of displacement of the medical device within thepatient's body when the medical device is separated from the probe ormedical device.

SUMMARY

The present invention is directed to an ultrasound needle guidancesystem that facilitates placement of an ultrasound monitor over apatient and ensures accurate and simple needle placement in a target ofinterest within a patient's body. According to an embodiment of theinvention, a hand-held ultrasonic probe includes a needle guidanceposition that holds a needle. The needle is orientated transverse to thescanning plane of the transducer. The needle can be rotated through acontinuous range of angles and these angular changes can be tracked anddisplayed as a cross-hair (or other type of visual indicia) on a nearbymonitor screen with the ultrasonic image. In this way, a healthprofessional can accurately track and locate a needle to ensure preciseplacement at a target within a patient's body.

In another embodiment, an ultrasonic probe includes a hand-held body, atransducer contained within the body and adapted for generatingultrasonic images of a scanning plane, and a needle guide coupled to thebody and rotatable about an axis that is in a plane parallel to thescanning plane. The probe may include a position detector for detectingthe rotation of the needle.

In another embodiment, an ultrasonic probe includes a hand-held body, atransducer contained within the body and adapted for generatingultrasonic images of a scanning plane, a shaft mounted within the bodyand configured to rotate through an angle that is in a plane transverseto the scanning plane, a position detector coupled to the shaft, and anarm configured to receive a needle holder, connected to the shaft andextending out of the body. The body may be a sterile shell of a bodythat holds the transducer. The arm may be restricted to rotate within atransverse plane.

In another embodiment, an apparatus for tracking the position of aneedle relative to an ultrasonic image includes a hand-held ultrasonicprobe having a scanning plane, a needle guidance portion including aneedle holder coupled to the probe for rotation about an axis that is ina plane parallel to the scanning plane, the needle holder defining aneedle path originating at the needle holder and extending through thescanning plane, and needle path data generated by the needle guidanceportion, wherein the needle path data locates the intersection of theneedle path and the scanning plane.

In another embodiment, a method for positioning a needle for treatmentof a target body within a patient using a hand-held ultrasonic probehaving a scanning plane is provided. This method includes the steps ofmounting a needle on the probe, the needle having an angular positionrelative to the scanning plane, placing the hand-held probe on thepatient, displaying a two-dimensional image of the scanning planeincluding the target body, the image including a visual indicia of theneedle position relative to the target body, rotating the needle aboutan axis that is in a plane parallel to the scanning plane whilemonitoring the corresponding movement of the visual indicia, and whenthe needle is aligned with the target body, placing the needle at thetarget body. According to this method, the needle may be placed at thetarget by rotating the needle while tracking the movement of a visualindicia of the needle's pathway on a display screen. Once the visualindicia aligns with the target, the needle is positioned appropriatelyfor placement at the target.

In another embodiment, a method of tracking the position of a needlerelative to a target body includes the steps of providing a hand-heldultrasonic probe having a scanning plane, mounting a needle on theprobe, the needle defining a needle path extending from the needle tothe scanning plane, rotating the needle guide in a plane transverse tothe scanning plane, and generating data locating the intersection of theneedle path and the scanning plane in response to rotation of the needleguide. This method may include the step of computing for a continuum ofangles through which the needle rotates the intersection of the needlepath and the scanning plane.

In another embodiment, a system for locating a needle insertion pointincludes a display, a hand-held ultrasonic probe defining a scanningplane, an ultrasonic image of the scanning plane, generated by the probeand displayed on the display, a needle guide coupled to the probe forrotational motion relative to the probe and about an axis that is in aplane parallel to the scanning plane, a position detector coupled to theneedle guide, position data generated from the position detector; and avisual indication of the needle position generated from the positiondata and displayed with the ultrasonic image on the display device.

In a preferred embodiment, the ultrasound system comprises a heightadjustable stand, an adjustable and moveable ultrasound monitor, aretractable cord, and a system of hooks allowing probe sterility whilemounted on the ultrasound machine. Connected to the ultrasound monitoris an ultrasound probe.

Preferably a removable sterile clip is used to mount the needle to theprobe. In this aspect of the invention, the clip is configured tominimize mechanical noise associated with removal of the probe from theneedle. As such, it is preferred to use a clip that does not rely on amechanical engagement to retain the needle in the needle clip.

In another embodiment of the invention, an ultrasonic probe includes aneedle clip that has a cradle for a needle and an arm having a first endcoupled to the cradle and a second end forming a cover. In thisembodiment, the cover is manually movable between a first positionopening the cradle and a second position closing the cradle. Also, thecover is detached from the cradle in the second position and when thecover is in the second position, the cover and cradle together form apassageway for a needle shaft disposable between the cover and cradlesuch that the passageway allows movement of the needle in a firstdirection and substantially prohibits movement of the needle in a seconddirection that is perpendicular to the first direction.

In another embodiment of the invention, a method of releasably fasteninga needle to an ultrasonic probe includes the steps of providing a needleclip on the probe, the needle clip including a displaceable arm and acradle adapted to receive a needle shaft, placing the needle shaftwithin the cradle, applying pressure to the arm such that the arm movesfrom a first position distal of the cradle to a second position proximalto and mechanically decoupled from the cradle, whereupon the needle isheld between the cradle and arm, and relieving the pressure on the arm,whereupon the arm moves from the second position to the first position.Alternatively, finger pressure may move the arm away from the cradle sothat when the finger pressure is relieved, the needle is retained withinthe cradle.

Preferably, the ultrasound probe is encompassed by a thin plasticsterile shell that allows access to a connector for mounting the needleclip.

In still another embodiment, an apparatus for tracking the position of aneedle relative to an ultrasonic image includes a hand-held ultrasonicprobe having a scanning plane, a needle guidance portion including aneedle holder coupled to the probe for rotation about an axis that is ina plane that is non-parallel with the scanning plane and perpendicularto a body surface to be penetrated by a needle received in the needleholder. For example, the axis may lie in a plane that makes at least a10, 15, 30, 45, 60, 75, between 45 and 90 degree, or up to 90 degreeangle with the scanning plane.

In another embodiment of the invention, a sterile shell for anultrasonic probe includes a first shell portion, a second shell portion,a third shell portion defining a chamber for receiving an end of theultrasonic probe. Living hinges may be used to rotatably connect thefirst, second and third shell portions together. Additionally, anacoustic coupling gel may be contained within the chamber and sealeduntil use by a removable lidstock, e.g., a plastic wrapper or foil.

In another embodiment of the invention, a method of sterilizing anultrasonic probe includes the steps of providing a sterile shell,including a first, second and third shell portion connected to eachother by living hinges, the third shell portion defining a chambercontaining a gel, removing a cover from the third shell portion, placinga waveguide of the probe inside the third shell portion, and placing thesecond and first shell portions over the probe, thereby enclosing theprobe within the shell.

Among the various advantages apparent from the description, there isprovided a particularly useful apparatus and method for administering anerve block or performing an acute angle catheter entry procedure.

These and other aspects of the present invention will become apparent tothose skilled in the art after a reading of the following description ofthe preferred embodiment when considered with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a front view of a ultrasound guidance system according to anembodiment of the present invention.

FIG. 1B is a side view of a monitor of the system of FIG. 1A.

FIG. 2 is a first front view of the monitor of FIG. 1B showing an imagegenerated by an ultrasound device and a cross hair indicating a firstangular orientation of a needle mounted to an ultrasound device.

FIG. 3 is a second front view of the monitor of FIG. 1B showing the sameimage generated by an ultrasound device and a cross hair indicating asecond angular orientation of the needle.

FIG. 2A is a first side view of an ultrasound probe of the system ofFIG. 1A and needle mounted thereto corresponding to the monitor image ofFIG. 2, with the probe placed on a patient and prior to inserting theneedle into the patient and the probe is enclosed in a sterile shell.

FIG. 3A is a second side view of the ultrasound probe of FIG. 2A andneedle mounted thereto corresponding to the monitor image of FIG. 3,with the probe placed on the patient and after the needle has beenplaced at a target within the patient and the probe is enclosed in asterile shell.

FIG. 4 is a side view of the ultrasound probe and sterile shell of FIG.1A.

FIG. 5 is a front view of the ultrasound probe and sterile shell of FIG.1A.

FIG. 5A is a perspective view of a portion of a needle guidance portionof the system of FIG. 1A.

FIG. 5B is a schematic illustration of the processing steps for needlepositioning data according to an embodiment of the present invention.

FIG. 6 is a perspective view of a second embodiment of an ultrasonicprobe enclosed in a sterile shell.

FIG. 7 is a perspective view of a sterile shell of the probe of FIG. 6.

FIGS. 8A and 8B are first and second perspective views of first andsecond parts of a first embodiment of a needle clip according to thepresent invention.

FIG. 8C is a perspective view of the needle clip of FIGS. 8A and 8Battached to the probe of FIG. 5.

FIG. 9 is a perspective view of a second embodiment of a needle clipattached to the probe of FIG. 5 according to an embodiment of thepresent invention.

FIG. 10 is a perspective view of a third embodiment of a needle clipattached to the probe of FIG. 5 according to an embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings in general, the illustrations are for thepurpose of describing preferred embodiments of the invention and are notintended to limit the invention thereto. FIG. 1A shows a preferredcart-based compact ultrasound needle guidance system 10. Among thefeatures of system 10 is a monitor 20 (preferably an LCD monitor) thatcan be easily positioned for optimal viewing during an ultrasoundimaging process, and an ultrasonic probe 30 that sends ultrasonic imagedata to monitor 20 via a cord 18. Probe 30 is preferably encased in asterile shell 31 that completely encloses probe 30. Probe 30 includes aneedle guidance device, rotatably mounted to probe 30, which enables ahealth professional to make angular adjustments to a needle mounted toprobe 30 during a procedure. Angular adjustments to the needle aredisplayed on monitor 20 in real time with the ultrasonic image so thatthe needle position can be tracked and aligned precisely with the targetlocated within the patient.

System 10 is lightweight, so that it may be moved about without greatdifficulty. A stand 11 supports system 10, which may include wheels tomove it about the floor. Stand 11 is connected to a height adjustablepole 13 which is connected at its upper end to a rotatable arm 17. Atightening collar 12 fixes pole 13 at a desired height and a lockablepivot 16 fixes arm 17 at a desired angle relative to pole 13. Thus, inpreparing system 10 for an ultrasound procedure, monitor 20 is movablesuch that it can be positioned directly in front of the user and overthe patient. This is accomplished by adjusting the height adjustablepole 13 and pivoting the rotatable arm 17 about the lockable pivot. Oncethe desired height is reached, height adjustable pole 13 and arm 17 arelocked into position by tightening collar 12 and pivot lock 16,respectively. The mobility and lightweight properties of system 10 lenditself to easy height and angular adjustments by a single healthprofessional.

System 10 is designed to avoid occurrences of “drift” during an invasivemedical procedure using an ultrasound imaging device. When a healthprofessional must switch his or her attention from the patient's body tothe monitor (so as to track the progress of the needle), the ultrasounddevice can become misaligned. System 10 avoids occurrences of drift byallowing selective placement of the monitor in a position so that thehealth professional may maintain his or her immediate attention on thepatient and the position/orientation of the ultrasonic probe 30 whileviewing an ultrasound image on monitor 20. Thus, system 10 may beoperated so that the probe and patient are within the same field of viewas the ultrasound image. This can reduce error rates, improve theaccuracy of the scan and or insertion of a needle and thus reduce thediscomfort to the patient and time taken for an invasive medicalprocedure.

When arm 17 is moved and locked in place, monitor 20 may require furtheradjustment so that the image appears in the correct orientation relativeto probe 30. This can be accomplished in one of two ways. The ultrasoundimage may be oriented electronically by rotating the image on thescreen, or monitor 20 may be repositioned by providing a pivotal mountfor monitor 20 on arm 17 so that monitor 20 may be tilted relative toarm 17. Either or both of the above approaches may be followed in orderto facilitate adjustability of the image so that a health professionalmay obtain an optimal viewing orientation of the ultrasound image.

Cord 18 is retractable within monitor 20 using a spring-and-ratchet orsimilar mechanism. This allows cord 18 to be pulled in and out ofmonitor 20 to a desired length. Alternatively, a wireless communicationlink may be substituted for cord 18. In this embodiment, probe 30 mayfurther include a portable and replenishable power source such as arechargeable battery. Referring to FIG. 1B, a latch or hook 15 ismounted to monitor 20 and pivotal about a rotatable mount 14. Probe 30may be stored and maintained in a sterile condition on hook 15 when notin use. A ring or other suitable latching structure may be provided oncord 18 near probe 30 for latching to hook 15. If a wireless probe isused, then a suitable latching device may be provided at the upper endof probe 30. Hook 15, being mounted to a free pivot 15 that is rotatablewithin the plane of the monitor screen, allows a latched probe 30 tohang in a vertical position from monitor 20 regardless of monitor 20orientation. With this arrangement, system 10 provides a convenientlocation for storing probe 30 when it is not needed, minimizes movementand operator error during a procedure, and yet still maintains probesterility.

FIGS. 4 and 5 illustrate side and front views, respectively, of probe30. Probe 30 includes an ultrasound transducer, which generates theimage data transmitted to monitor 20. This image data is used togenerate real time images of the patient's body below the skinline. Asshown, probe 30 is preferably encased within a sterile shell 31 whenperforming a procedure. This ensures sterility during a procedure. Asterile sleeve may also be used. In an alternative embodiment, a sterilesleeve may be secured at an upper end of probe 30 and extend upwardly toenclose cord 18. This sleeve may be included with shell 31 or attachedseparately. As described in greater detail, below, the transducer isconveniently encased within sterile shell 31 by enclosing the transducerbetween front and rear shell parts, and a front part which encloses theforward end, i.e., the area designated by 37 in FIG. 5.

Probe 30 may be equipped with any suitably chosen, commerciallyavailable transducer. For example, probe 30 may be configured as alinear or curved array type and may be adapted for scanning within highfrequency bandwidths (e.g., 10-15 MHz) for viewing near the skin surfaceor low frequency bandwidths (e.g., below 5-7 MHz) for viewing well belowthe skin surface. Ultrasonic image data can be generated and processedfor display on monitor 20 using any suitably chosen ultrasound system.

Acoustic signals are transmitted/received through a lower surface 37 ofthe transducer such that a scanning plane B covers an area below probe30 as illustrated in FIGS. 4 and 5. At a lower end of probe 30 there isa needle guidance portion 40. Needle guidance portion 40 is used tomount a needle to probe 30 and permits a health professional to makecontinuous angular adjustments to the needle relative to scanning planeB during an ultrasound procedure. Thus, system 10 does not require ahealth professional to pre-select an angular orientation of the needle.Rather, a precise angular orientation can be determined while an imageis generated of the area beneath the skin.

As seen in FIG. 5A, needle guidance portion 40 includes a rotatableshaft 43 and a clip connector 44 extending perpendicularly from shaft43. Clip connector 44 extends through an opening 35 formed on shell 31so that it may releasably receive a needle clip, e.g., needle clip 200shown in FIG. 8C. The needle is then mounted to needle clip 200. Whenmounted to needle guidance portion 40, the needle may be rotated througha continuum of angular positions relative to scanning plane B. Inparticular, needle guidance portion 40 is arranged so that angularpositions of the needle are measured about an axis that lies in a planeparallel to scanning plane B. Hence, probe 30 is configured forselectively positioning a needle in a plane transverse to scanning planeB.

With reference to FIGS. 5, 5A and 8C, shaft 43 includes a bearing 43 athat is received within a housing 34 of shell 31. This housing 34permits rotational motion of shaft 43 and hence clip connector 44 aboutan axis A (FIGS. 5 and 5A), which lies in a plane parallel to scanningplane B. An opening 35 is formed on housing 34 so that clip connector 44may extend out from shell 31 and rotate through a predetermined range ofangles. In another embodiment, clip connector 44 may be disposed so thatit is inset from, or flush with opening 35 of shell 31. This embodimentmay be preferred since clip connector 44 is fixed to probe 30 and hencenot sterile. By having clip connector 44 recessed within opening 35,potential contamination of shell 31 may be avoided.

A needle clip 200 is attached to clip connector 44 by placing clipconnector 44 within a hollow post 224 formed on needle clip 200 andengaging a snap-fit provided by depressions 44 a formed on clipconnector 44 and mating ledges formed on inner surfaces of post 224.Other means may be used for disengagably mounting clip 200 to clipconnector 44. Needle clip 200 may also include a skirt formed near alower end of post 224. The skirt is intended to cover opening 35 whenneedle clip 200 is mounted to clip connector 44, without obstructingrotation of needle clip 200 about probe 30, so as to further reduce thechance of contamination during a procedure. A shaft of the needle isreceived in a cradle portion 204 of needle clip 200 and releasably heldtherein by a fastening arm 216 during the procedure. The snap-fitengagement between post 224 and clip connector 44 is preferably easilyreleasable so as to enable a health professional to remove needle clip200 from clip connector 44 after a procedure is completed. It ispreferred that needle clip 200 is a disposable needle clip and thusreplaceable after every procedure to maintain sterility. Needle clip 200is placed on clip connector 44 after the transducer of probe 30 has beenwrapped in a sterile sleeve or encased within a first embodiment of asterile shell 31 as shown in FIG. 5.

In the preferred embodiments, needle guidance portion 40 includes aneedle tracking device that tracks the angular position of the needle asit rotates about axis A. For example, in the embodiment illustrated inFIG. 5A, a potentiometer 45 is rotatably coupled to shaft 43 and used todetermine angular displacements (or velocities) of a needle as itrotates about axis A. Shaft 43 is coupled to potentiometer 45 by, e.g.,engaging a threaded end 46 of shaft 43 with a rotor portion ofpotentiometer 45. It will be appreciated that any suitably chosen,commercially available tracking device may be used in place ofpotentiometer 45. For example, shaft 43 may be coupled to a positionencoder for detecting angular motion of shaft 43. In another embodiment,needle rotation relative to probe 30 may be accomplished using a livinghinge. Potentiometer 45 illustrated in FIG. 5A is part of apotentiometer circuit (not shown) that transmits electronic signals to aprocessor. These signals are used to produce real-time video images ofthe needle's angular position relative to scanning plane B. Positiondata from the potentiometer circuit may be transmitted to monitor 20separately from signals transmitted by the transducer, or they may becombined into one signal. In one embodiment, angular position data isprocessed separately from data from the transducer using softwareassociated with monitor 20 or a separate computer connected to monitor20. This software produces a real-time, continuous image of the needleorientation that is superimposed over the ultrasound image. In otherembodiments, transducer and angle measuring data may be processedsimultaneously so as to produce a single data stream that is fed tomonitor 20. The software used to process needle position information maybe incorporated into probe 30 or reside at a separate computer.

The schematic illustration of FIG. 5B describes one embodiment of thesteps that may be used to convert movement of the needle mounted toprobe 30 into a video image on monitor 20. As shown, needle rotationthrough an angle θ is detected by the angle detector, which in thisexample is a potentiometer. The analog signal produced by potentiometer45 is converted into a digital signal. A digital position encoder may beused in place of potentiometer 45. The digital signal is then convertedinto an angle based upon stored potentiometer calibration data. Thisangle data is then converted into a depth relative to the ultrasonicimage using stored X, Y offset parameters. These parameters are obtainedfrom calibration data and reflect the offset position of the needlerelative to scanning plane B. The depth position is then combined withthe ultrasonic image data and displayed on monitor 20, e.g., thecross-hair 62 a illustrated in FIGS. 2 and 3.

Operation of probe 30 in connection with monitor 20 will now bedescribed with reference to FIGS. 2, 2A, 3 and 3A. FIGS. 2A and 3Aillustrate side views of probe 30 with needle clip 200 secured to clipconnector 44 and a needle 50 received in needle clip 200. Probe 30 isencased in sterile shell 31. A tip of needle 50 is positioned adjacentto, but not penetrating the patient's skinline C in FIG. 2A whereas inFIG. 3A the shaft of needle 50 is inserted into the patient and properlylocated at target 64. FIG. 2A shows needle 50 orientated at a firstangle θ₁ relative to a scanning plane B of the transducer and FIG. 3Ashows needle 50 orientated at a second angle θ₂ relative to scanningplane B. Dashed lines D and E represent the pathways for needle 50 whenorientated at the respective angles θ₁, θ₂ and distance δ in FIG. 3A isthe distance along pathway E from the skinline C that needle 50 must beinserted in order to reach target 64. The term “needle pathway” refersto the path needle 50 will take if inserted into the patient's skin at agiven angle relative to the scanning plane B. As can be seen in FIG. 2A,needle pathway D intersects plane B above the intended target 64 whenorientated at angle θ₁. If needle 50 is inserted at this angle, needle50 will miss target 64. However, when needle 50 is orientated at angleθ₂ relative to scanning plane B, needle 50 will follow needle pathway Eand intersect scanning plane B at the target 64.

It is desirable to have both the correct needle pathway and insertiondepth identified before needle 50 is inserted. This will minimizediscomfort to the patient (caused by adjustments to the needle positionafter the needle has penetrated the skin) and/or simplify the process ofpositioning a needle at a target, which reduces the skill level and timeneeded to place a needle at target 64. Moreover, it is important to knowthe depth of needle insertion as this will increase the chances foreffective administration of the needle contents at a target and ensurethat the needle tip does not cause undue damage to neighboring tissue.

At present, the health professional often times has to rely solely uponan ultrasound image of the living body, e.g., tissue deformation such asbuckling of a blood vessel wall, when deciding whether or not the needlehas reached the intended target. In cases where there is no change inthe ultrasound image of the living body to indicate a needle location,e.g., when applying a local anesthesia to block a nerve, a healthprofessional must rely on his or her knowledge of the patient's anatomy,which is only an approximation. If a health professional could obtainaccurate information of both the needle pathway, target location and theactual insertion depth of the needle, then the needle can be moreprecisely placed at the target.

System 10 is configured to provide a health professional with a visualindication of the needle pathway needed to intersect plane B at thetarget 64 and the insertion depth needed to place the tip of the needleat the target 64 (insertion distance δ). FIGS. 2 and 3 show images 60 aand 60 b, respectively, generated on monitor 20 that correspondrespectively to the position of probe 30 and needle 50 illustrated inFIGS. 2A and 3A. Cross hairs 62 a and 62 b indicate the point ofintersection between the respective needle pathways D and E and scanningplane B. A cross section of a blood vessel wall is also shown in FIGS. 2and 3 with a section of the vessel wall corresponding to target 64.Image 60 a indicates that the needle pathway D will intersect plane Babove target 64 (cross hair 62 a), which means that needle pathway D istoo shallow. Image 60 b indicates that the needle pathway will intersectplane B at target 64 (cross hair 62 b covers target 64), which meansthat needle pathway E is the correct pathway for needle 50.

The insertion distance δ for needle 50 may be obtained from theinsertion angle θ₂ and other known distances which may be stored withthe X, Y Position Parameters discussed earlier. For example, theinsertion depth may be determined from θ₂, the distance from surface 37and target 64, the horizontal distance between the needle shaftcenterline (at the needle clip) and the scanning plane B and thevertical distance between the needle shaft centerline (at the needleclip) and the bottom surface of probe 30. Once obtained, the needleinsertion depth may be matched to distance δ by providing score lines onneedle 50 or a stopper member that prevents needle 50 from beinginserted beyond the desired depth. For certain procedures, the healthprofessional may not need to know δ in order to ensure accurateplacement. For example, if needle 50 is intended for a blood vesselwall, a visually identified buckling of the vessel wall, flow of bloodthrough the needle shaft passage or change in resistance to needle 50penetration may be sufficient to confirm accurate placement. In otherapplications, such as when applying a local anesthetic to block a nerve,knowledge of δ may be useful in locating the target, or the healthprofessional may again rely on tissue changes in the ultrasonic image.On the ultrasound screen, indirect or secondary signs of needle locationmay include soft tissue deformation indicating that the needle ispassing through that tissue, and a hypoechoic acoustic shadow and ringdown artifact when the sound beam hits the needle. All of thesesecondary signs are important when the needle itself is not visualized.The crosshair (or another suitably chosen indicia) may provide a focuspoint to watch for the formation of these secondary signs. Since theneedle pathway is shown on monitor 20, the health professional can focushis or her attention on the cross hair. Once the needle is located atthe target by primarily visualizing the needle itself or by one of thesecondary indicators above, a small portion of local anesthetic can beinjected and may be detectable by the reflected sound waves so that achange in the ultrasonic image appears at the displayed cross hair.Likewise, once the needle tip is placed at the target by directvisualization or by secondary signs, the ultrasound guidance system canrelease the needle and then the transducer can be orientated in parallelwith the needle insertion to visualize the entire length of the needleincluding the tip in relation to the target.

With reference to FIGS. 2, 3, 2A and 3A, accurate positioning of needle50 with respect to its intended target 64 proceeds as follows. First,monitor 20 is positioned within the health professional's immediatefield of view of the patient and ultrasound device, so as to avoid anyoccurrence of drift during the procedure. If, initially, monitor 20displays a cross hair, e.g., cross hair 62 a, above the target, then theneedle pathway needs adjustment. This is done by rotating the angle ofinsertion of the needle 50 clockwise in FIG. 3A (of course, if crosshair 62 a were located below target 64, then needle 50 would be rotatedcounterclockwise in FIG. 3A). This rotational motion is detected by achange in resistance in the potentiometer circuit. The processed signalproduces real-time angular positional information for the needle pathwaywhich is represented on monitor 20 as a downwardly moving cross-hair. Asthe needle pathway is adjusted downward by rotating needle 50,cross-hair 62 a moves downward and towards target 64 until it reachestarget 64, which corresponds to cross-hair 62 b. Once the cross-hair iscentered on the target, the desired needle pathway is located. It isdesirable that, after the needle pathway is found, clip is able to stayin the corresponding position via a preset rotational resistance inshaft 43 of needle guidance portion 40. Preferably, the rotationalresistance is provided to the shaft 43 by friction and a dampenercoupled to shaft 43. Alternatively, the potentiometer assembly mayprovide the rotational resistance to shaft 43. Because the rotationalresistance holds the needle in place without user assistance, the needlepathway can be reliably maintained. After needle pathway E is found,needle 50 can be inserted the distance δ(θ₂) where target 64 is located.Once at target 64, probe 30 may be removed from needle 50. After probe30 has been removed from needle 50, probe 30 may be set aside via theprobe mounting hook 15 which is attached to monitor 20, as discussedearlier. Alternatively, probe 30 may be set aside onto the sterile fieldvia the sterile shell 31 and an optional sterile sleeve that will extenddown the length of the ultrasound cord 18. This maintains probe and cordsterility in the event that probe 30 is needed again. The remainder ofthe procedure may be performed in usual sterile fashion.

Assembly of probe 30 includes calibration of the needle guidance portion40. That is, calibration of the changes in the potentiometer circuitwith respect to changes in the needle angle and calibration of the angledata with depth positions on the ultrasonic image, e.g., cross-hairlocations relative to the image plane displayed on monitor 20. It willbe appreciated that the potentiometer (or position encoder) may becalibrated using any known method. After the angle data has beencalibrated with respect to changes in the potentiometer circuit,incremental angular rotations of the needle may be determined fromincremental changes in the potentiometer circuit using any well knowninterpolation algorithm. Depth position data, e.g., X, Y OffsetParameters of FIG. 5B, are then computed. These depth position datainclude the offset position of the needle pathway relative to thepotentiometer and the position of the potentiometer relative to thetransducer. These parameters are then used with the computed angularchanges to compute the depth positions, i.e., the intersection of theneedle pathway on the image plane.

As mentioned earlier, a needle guidance portion 40 is arranged so thatangular positions of the needle are measured about an axis that lies ina plane parallel to a scanning plane B. Hence, probe 30 is configuredfor selectively positioning a needle in a plane transverse to scanningplane B. In other embodiments, angular positions of the needle aremeasured about any axis that lies in a plane perpendicular to a bodysurface to be penetrated by a needle received in the guidance portion,but not a plane that is parallel to the scanning plane. For example,angular positions may be measured with respect to a rotation axis thatlies in a plane that makes at least a 10, 15, 30, 45, 60, 75, between 45and 90 degrees, or up to 90 degree angle with the scanning plane. Inthese embodiments, the needle guidance portion may be constructed in asimilar manner to needle guidance portion 40, but with its mounting tothe transducer being such that the shaft about which the needle rotatesis orientated so that the needle rotates in a plane perpendicular to abody surface to be penetrated by the needle but not a plane that isparallel to the scanning plane. Such embodiments can still offer thevarious advantages of the earlier disclosed embodiments, such astracking a needle position relative to a target and aligning the needlewith a target.

As mentioned, probe 30 is preferably encased in a sterile, disposableshell 31. Shell 31 is configured with a housing 34 that receives needleguidance portion 40, which is fit to an external portion of thetransducer and encases the entire transducer. When fitting shell 31 tothe transducer and needle guidance portion 40, a front and rear shellportion may be used in which the front and rear shell portions arebrought together and held together by, e.g., snap fasteners.

A second embodiment of a sterile shell is illustrated in FIGS. 6 and 7.Shell 100, like shell 31 of the first embodiment, is a clamshell formedto cover the entire probe. However, shell 100 is formed to cover anembodiment of the ultrasonic probe where the needle guidance portion isintegrated into the transducer body. Thus, in this embodiment, there isno need to provide a housing portion shaped for receiving needleguidance portion 40 as these components are provided with the transducerbody. Shells 31 and 100 are preferably formed by injection molding, madeof relatively rigid plastic, which is easily sealable, less prone torips or tears than a conventional sleeve, and has an optional sleeve forprocedures that require a sterile cord.

With reference to FIG. 6, shell 100 includes an upper portion 104, alower portion 102 and a forward portion 106 encasing probe 30. A forwardsurface 107 of forward end 106 allows acoustic waves to pass throughwithout appreciable attenuation. A rear end 110, formed by portions 102and 104, provides an opening for a cord connecting probe 30 to monitor20. A raised region 108 includes a slotted hole 108 a sized to allowclip connector 44 to move freely within a predetermined range of anglesfor purposes of adjusting the angular orientation of a needle mounted tothe probe, as discussed earlier. In an alternative embodiment, clipconnector 44 may be disposed so as to be recessed within, or flush withhole 108 a so as to maintain sterility. Additionally, needle clip 200(receivable on clip connector 44) may be provided with a skirt near theend of post 224 so as to cover hole 108 a for purposes of maintainingsterility, but without obstructing rotation of needle clip 200, asdiscussed earlier.

A pair of snap connectors 112, 114 or other suitable fasteners are usedto hold upper and lower portions 102, 104 together. FIG. 7 illustratesshell 100 before enclosing the probe within. Shell 100 is a one-piececonstruction. Forward portion 106 is connected to upper portions 104 andlower portions 102 by living hinges 106 a and 106 b. The design of shell100 is such that forward end 106 may be used as a container for acousticcoupling gel. Hence, shell 100 may be provided with acoustic gel incontainer area 116 and sealed by a removable lidstock.

The probe may be encased within shell 100 as follows. First, a lidstocksealing the acoustic gel is pealed off. This exposes the acoustic geland allows the transmitting end of the probe to be inserted into space116. Next, portions 102 and 104 are brought together by rotation aboutliving hinges 106 a, 106 b until edges 102 b, 102 a, 104 a and 104 bmate together to form a sterile barrier. In order to facilitate a goodsterile barrier, cooperating lap joints are formed on edges 102 b, 102a, 104 a and 104 b. Male portions 112 a, 114 a and female portions 112b, 114 b of snap connectors 112, 114 are then joined together by a snapfit. A protrusion is formed on the male portions 112 a, 114 a so thatwhen it is time to remove the probe from shell 100, snap connectors 112,114 may be disengaged by pressing down on male portions 112 a, 114 a.

As discussed above and described in greater detail, below, a disposableneedle clip is used to secure a needle to the probe, e.g., probe 30 andthis needle clip is attached to probe 30 at clip connector 44 afterprobe 30 is enclosed in shell 100. Needle clip 200, like shells 31 and100, is sterile and stored sterilely until use. Therefore, potentialcontamination is minimized when snapping the shell onto the probe. Theissue of maintaining sterility may be addressed by two features. First,clip connector 44 may be disposed so as to not extend beyond opening 35or 108 a of the completely closed shells 31 and 100. This preventscontamination of the shell opening by the non-sterile clip connector.Second, needle clip 200 may have a skirt that covers but does not touchthe opening of hole 35 or 108 a. This provides a second barrier and atortuous path to prevent potential contamination of the sterile shell.Ideally, a needle clip and sterile shell are made available inpre-manufactured sterile kits each containing a sterile gel packet, ashell, at least one needle clip, and an optional sterile sleeve for thecord. Thus, there is provided a sterile external surface around theultrasound probe and cord while allowing a needle clip and clipconnector to rotate and be monitored by a potentiometer assembly.

Needle clip will now be described in greater detail with reference toprobe 30. Needle clip is preferably designed so that the healthprofessional may easily engage and disengage the needle clip as well assecure and release, respectively, a needle from probe 30 during theprocedure. In particular, it is desirable that the needle clip bedesigned so that probe 30 may be disengaged from needle 50 so as tominimize any movement of the needle shaft while it is embedded withinthe patient. First, second, third and fourth embodiments of a needleclip will now be described with reference to FIGS. 8-11.

With reference to FIGS. 8A, 8B and 8C, a first embodiment of a needleclip 200 includes a first part 201 (FIG. 8A) and a second part 202 (FIG.8B). In another embodiment, parts 201 and 202 may be a unitary, asopposed to a two-piece construction. A semi-circular cradle 204 forreceiving the shaft of a needle is formed on second part 202. Secondpart 202 is sized for sliding engagement within a holding portion 226 offirst part 200. When inserted in holding portion 226, ridges 212 a, 212b engage with channels 228 a, 228 b, respectively, which are formed onside walls 226 a, 226 b of holding portion 226. A wall portion 208 ofsecond part 202 has a surface 210 for abutment against surface 226 c ofholding portion 226 when second part 202 is completely received inholding portion 226. This contact between wall surface 210 and surface226 c ensures that second part 202 will stay in holding portion 226.Flexible fingers may be formed at an end of second part 202 forproviding a positive connection between first part 201 and second part202. The assembled needle clip 200 is secured to clip connector 44 byplacing a hollow post 224 formed on first part 200 over clip connector44. FIG. 8C illustrates the assembled needle clip 200 secured to clipconnector 44 of probe 30.

Referring to FIGS. 8A and 8C, first part 201 includes a fastening arm216 secured to post 224 by a flex member 222. At a first end 216 a offastening arm 216 a finger rest 220 is provided and at an opposite end acover 216 b is disposed adjacent to the holding portion 226. Flex member222 has a curved shape which allows it to be easily bent towards holdingportion 224 by finger pressure applied at finger rest 220. Clipconnector 200 retains a needle in cradle 204 by applying constant fingerpressure at finger rest 220. When finger pressure is applied to fingerrest 220 (represented by force F in FIG. 8C), flex member 222 bendstowards holding portion 226, which causes cover 216 b to extend overcradle 204 (direction d₁ in FIG. 8C), thereby trapping the needle shaftbetween cover 216 b and cradle 204. When it is time to separate theneedle from the probe 30, the user simply removes the finger pressureapplied to finger rest 220, which causes flex member 22 to return to itsundeformed position, FIG. 8C, and cover 216 b to move back to itsinitial position. By this action, the needle shaft can be separated fromprobe 30 without any extra movements, without the help of another healthprofessional, without disengaging any mechanical connection and hencewith minimal or no disruption to the needle shaft while it is embeddedin the patient.

Second and third embodiments of a needle clip will now be described withreference to FIGS. 9 and 10. In the second embodiment, there is a firstpart and a second part to the needle clip, which can be secured to theclip connector 44 in the same fashion as needle clip 200. In the thirdembodiment, there are three parts to the needle clip. The same structureassociated with the holding portion, post and second part as describedabove for needle part 200 is used in these other embodiments(alternatively, a one-piece and two-piece construction may be chosenover a two-piece and three-piece construction for these embodiments,respectively). However, these other embodiments differ in the structureand method of actuation associated with the fastening arm. Accordingly,discussion of the second and third embodiments will proceed with theunderstanding that the structure and functionality of the remainingstructure associated with the needle clip will be readily understood inview of the discussion of the first embodiment.

A second embodiment of a needle clip 400 will now be described withreference to FIG. 9. In this embodiment, fastening arm 416 (attached topost 226 at front and back sides thereof) has a curved portion 417 thatextends around holding portion 426 so that cover 416 b is disposedadjacent to, and on the opposite side of cradle 204. Cover 416 b extendsover cradle 204 when finger pressure is applied, as in the firstembodiment. Actuation of cover 416 b is accomplished by pressingdownward on finger rest 420, which causes cover 416 b to move overcradle 204 (direction d₃) so that the needle shaft becomes trappedbetween cradle 204 and cover 416 b. Needle may be removed form cradle204 by releasing finger pressure so that cover 416 b displaces back toits starting position (FIG. 9).

A third embodiment of a needle clip 500 will now be described withreference to FIG. 10. In this embodiment, a fastening arm 516 isslidingly received in a grooved section 522 of first part 201 that isdisposed adjacent to cradle 204. A flex member 524 is attached tofastening arm 516 at a lower surface 516 a and is adapted to abut asurface 524 a of probe 30, which causes flex member 524 to flex towardsfinger rest 520 when finger pressure is applied at finger rest 520.Before finger pressure is applied, cover 516 b does not cover cradle204. When finger pressure is applied, cover 516 b extends over cradle204, thereby trapping needle shaft between cradle 204 and cover 516 b.While finger pressure is applied, flex member 524 is maintained in aflexed state. When finger pressure is removed, flex member 524 will movecover 516 b back to its original position (i.e., not covering cradle204) as it returns to its undeformed state. Needle shaft may then beseparated from probe 30. This embodiment, like the others described, canbe used to separate needle shaft from probe 30 without disengaging anymechanical connection and hence with minimal disruption to the needleshaft while it is embedded in the patient.

Certain modifications and improvements will occur to those skilled inthe art upon a reading of the foregoing description. By way of example,the sterile shell can be made to work with any existing ultrasoundprobe, providing a more convenient and operable sterile covering thantraditional probe sleeves. Also, the cart-based compact ultrasoundsystem can be modified to work with other types of available probes,providing a more complete and user friendly portable ultrasound system.Further, the present invention can be configured to work withthree-dimensional and four-dimensional (real-time three-dimensional)ultrasound in addition to the above described embodiment using real-timetwo-dimensional ultrasound. All modifications and improvements have beenomitted herein for the sake of conciseness and readability but areproperly within the scope of the present invention.

What we claim is:
 1. An ultrasonic probe comprising: a transduceradapted for generating ultrasonic images of a scanning plane; a shaftoperably coupled to the transducer, the shaft rotatable about an axisparallel to the scanning plane; a position detector coupled to theshaft; and a needle holder connected to the shaft and extendingoutwardly therefrom, the needle holder rotatable with the shaft, theneedle holder comprising a needle holding portion configured to receivethe shaft of a needle and providing an anticipated needle pathcorresponding to the shaft of the needle, the anticipated needle pathbeing opposed to the scanning plane.